Zealand Pharma (CPH: ZEAL) has enrolled and dosed all subjects in its second and pivotal Phase 3 trial investigating dasiglucagon for the rescue treatment of severe hypoglycaemia in patients with type 1 diabetes, the company announced on Monday.
Dasiglucagon is a potential first-in-class soluble glucagon in a ready-to-use rescue pen, the HypoPal, to treat severe hypoglycaemia.
Results from Phase 2 clinical studies showed that dasiglucagon rapidly increased plasma glucose levels after insulin-induced hypoglycaemia. When compared to the active comparator, dasiglucagon resulted in a longer-lasting and more pronounced plasma glucose increase.
The primary aim of this second and pivotal Phase 3 trial is to confirm a rapid increase in plasma glucose after single dose administration of dasiglucagon (0.6mg) to type 1 diabetes mellitus subjects with insulin-induced hypoglycaemia in comparison to placebo.
The parallel, randomised, double-blind trial involved 156 type 1 diabetes patients, who were exposed to either dasiglucagon, placebo, or reconstituted glucagon. Results are expected in Q3 2018.
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